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The Veterinary Medicines Regulations 2013
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[F1Application for a marketing authorisation for a pharmaceutical [F2, immunological or biological that is not immunological] veterinary medicinal product]E+W+S
This section has no associated Explanatory Memorandum
7. The following table sets out the fees relating to a pharmaceutical [F3, immunological or biological that is not immunological] veterinary medicinal product for—
(a)[F4an application] for a marketing authorisation that is—
(i)a full application under Part 1 of Schedule 1; [F5or]
(ii)a bibliographic application [F6for a pharmaceutical veterinary medicinal product]; F7...
F8(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F9(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F10(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| [F11Application | Fee (£) per authorisation |
|---|---|
| Base fee | 27,995 |
| Fee for 1st additional strength | 4,590 |
| Fee for each subsequent additional strength | 1,465] |
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Sch. 7 para. 7 heading substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Sch. 7 para. 7 heading inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 164(d)
F3Words in Sch. 7 para. 7 inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 164(a)
F4Words in Sch. 7 para. 7(a) substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F5Word in Sch. 7 para. 7(a)(i) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 164(b)(i)
F6Words in Sch. 7 para. 7(a)(ii) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 164(b)(ii)(aa)
F7Word in Sch. 7 para. 7(a)(ii) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 164(b)(ii)(bb)
F8Sch. 7 para. 7(a)(iii) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 164(b)(iii)
F9Sch. 7 para. 7(b) omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
F10Sch. 7 para. 7(c) omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
F11Sch. 7 para. 7(c) Table substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 164(c)
Specified pharmaceutical applicationsN.I.
7. The following table sets out the fees relating to a pharmaceutical veterinary medicinal product for—
(a)a national application for a marketing authorisation that is—
(i)a full application under Part 1 of Schedule 1;
(ii)a bibliographic application; or
(iii)an application based on pharmacological equivalence;
(b)an application for a marketing authorisation using the decentralised procedure where the United Kingdom is a concerned member State;
(c)an application for the mutual recognition of a product authorised in another member State.
| Application | Full national application under Part 1 of Schedule 1 (£) | Bibliographic national application (£) | Pharmacologically equivalent national application | Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£) | ||
|---|---|---|---|---|---|---|
| Reference product authorised in UK (£) | Reference product not authorised in UK (£) | |||||
| Base Fee: | 13,530 | 12,115 | 7,195 | 9,220 | 6,515 | |
| Additional fee if any of the target species is a food-producing animal: | 3,905 | 3,585 | 2,155 | 2,760 | 1,415 | |
| Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom— | ||||||
| food-producing animal: | 7,465 | 6,595 | 5,885 | 7,495 | 2,630 | |
| non-food-producing animal: | 6,525 | 5,855 | 5,590 | 7,155 | 2,295 | |
| Additional fee for each additional pack type: | 740 | 740 | 605 | 775 | 330 | |
| Additional fee for each additional active ingredient (food-producing animal): | 6,465 | 6,125 | 4,040 | 5,165 | 2,085 | |
| Additional fee for each additional active ingredient (non-food-producing animal): | 4,310 | 4,105 | 3,235 | 4,135 | 1,475 | |
| Additional fee if there is more than one target species, for each additional species (food-producing animal): | 3,970 | 3,565 | 2,425 | 3,100 | 1,280 Applies for a maximum of 2 additional species | |
| Additional fee if there is more than one target species, for each additional species (non- food-producing animal): | 2,495 | 2,090 | 1,550 | 1,980 | 805 Applies for a maximum of 2 additional species | |
| Additional fee for each additional recommended route of administration (food-producing animal): | 2,695 | 2,490 | 1,620 | 2,070 | 940 | |
| Additional fee for each additional recommended route of administration (non- food-producing animal): | 1,215 | 1,010 | 740 | 945 | 405 | |
| Simultaneous applications: fee for each additional product in the application: | 2,895 | 2,895 | 2,895 | 3,705 | 1,685 | |
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
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